A Study to Assess Collagenase Clostridium Histolyticum (CCH) in the Treatment of Plantar Fasciitis (PFA)
NCT ID: NCT06169319
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
231 participants
INTERVENTIONAL
2024-01-03
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1: CCH High Dose
Participants will receive a high dose of CCH on Day 1.
Collagenase Clostridium Histolyticum (CCH)
Biologic: Intrafascial injection
Group 2: CCH Low Dose
Participants will receive a low dose of CCH on Day 1.
Collagenase Clostridium Histolyticum (CCH)
Biologic: Intrafascial injection
Group 3: Placebo
Participants will receive matching placebo on Day 1.
Placebo
Intrafascial injection
Interventions
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Collagenase Clostridium Histolyticum (CCH)
Biologic: Intrafascial injection
Placebo
Intrafascial injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a diagnosis of plantar fasciitis for ≥6 months, which has not responded to conservative therapies. Conservative therapies may include rest, physical therapy, splinting/bracing, orthotics, icing, physiotherapy, acetaminophen, corticosteroids, or nonsteroidal anti-inflammatory drugs (NSAIDs).
* Have current foot pain due to plantar fasciitis.
Exclusion Criteria
* Has a clinically meaningful laboratory abnormality.
* Has a body mass index ≥35 kilograms per meter squared (kg/m\^2).
* Has a known bleeding disorder, which, in the investigator's opinion, would make the participant unsuitable for enrollment in the study.
18 Years
75 Years
ALL
No
Sponsors
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Endo Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Endo Pharmaceuticals
Locations
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Endo Site 8
Tucson, Arizona, United States
Endo Site 20
Castro Valley, California, United States
Endo Site 13
Corona, California, United States
Endo Site 6
Encinitas, California, United States
Endo Site 11
Fresno, California, United States
Endo Site 16
Los Angeles, California, United States
Endo Site 40
Los Angeles, California, United States
Endo Site 21
San Francisco, California, United States
Endo Site 10
Tarzana, California, United States
Endo Site 37
Coconut Creek, Florida, United States
Endo Clinical Site 3
Pinellas Park, Florida, United States
Endo Site 14
Sweetwater, Florida, United States
Endo Site 7
Lawrenceville, Georgia, United States
Endo Site 23
Stonecrest, Georgia, United States
Endo Site 31
North Chicago, Illinois, United States
Endo Site 28
O'Fallon, Illinois, United States
Endo Site 33
Overland Park, Kansas, United States
Endo Site 35
Shreveport, Louisiana, United States
Endo Clinical Site 2
Pasadena, Maryland, United States
Endo Site 19
Grand Rapids, Michigan, United States
Endo Site 27
Missoula, Montana, United States
Endo Site 38
Westwood, New Jersey, United States
Endo Site 25
Moore, Oklahoma, United States
Endo Site 39
Portland, Oregon, United States
Endo Site 36
Malvern, Pennsylvania, United States
Endo Clinical Site 4
Bedford, Texas, United States
Endo Site 24
Burleson, Texas, United States
Endo Site 17
Dallas, Texas, United States
Endo Site 26
Dallas, Texas, United States
Endo Site 18
Dallas, Texas, United States
Endo Site 30
Fort Worth, Texas, United States
Endo Clinical Site 1
Georgetown, Texas, United States
Endo Site 15
Houston, Texas, United States
Endo Site 9
McAllen, Texas, United States
Endo Site 34
San Antonio, Texas, United States
Endo Site 22
San Antonio, Texas, United States
Endo Clinical Site 5
Salt Lake City, Utah, United States
Endo Site 32
Newport News, Virginia, United States
Endo Site 12
Suffolk, Virginia, United States
Countries
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Other Identifiers
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EN3835-227
Identifier Type: -
Identifier Source: org_study_id
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